Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K013321 |
Device Name |
SILICONE TRACHEAL T-TUBES |
Applicant |
TECHNICAL PRODUCTS, INC. |
2416 PARK CENTRAL BLVD. |
DECATUR,
GA
30035
|
|
Applicant Contact |
NORBERT D THOMPSON |
Correspondent |
TECHNICAL PRODUCTS, INC. |
2416 PARK CENTRAL BLVD. |
DECATUR,
GA
30035
|
|
Correspondent Contact |
NORBERT D THOMPSON |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 10/05/2001 |
Decision Date | 06/04/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|